A Randomized, Double-blind, Parallel-group Assessment of the Safety and Efficacy of Telmisartan 40mg Plus Hydrochlorothiazide 12.5mg (Micardis Plus) in Comparison With Losartan 50mg Plus Hydrochlorothiazide 12.5mg in Taiwanese Patients With Mild to Moderate Hypertension

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00133185
First received: August 22, 2005
Last updated: November 18, 2013
Last verified: November 2013
  Purpose

The primary objective of this trial is to compare the efficacy and safety of telmisartan 40 mg/hydrochlorothiazide 12.5mg (Micardis Plus) with that of losartan 50 mg/hydrochlorothiazide 12.5 mg, a reference AIIA combined with diuretic, in Taiwanese patients with mild to moderate hypertension.


Condition Intervention Phase
Hypertension
Drug: telmisartan 40 mg/hydrochlorothiazide 12.5 mg
Drug: losartan 50 mg/hydrochlorothiazide 12.5 mg
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Parallel-Group Assessment of the Safety and Efficacy of Telmisartan 40mg Plus Hydrochlorothiazide 12.5 mg in Comparison With Losartan 50 mg Plus Hydrochlorothiazide 12.5 mg in Taiwanese Patients With Mild to Moderate Hypertension

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Change from baseline in sitting diastolic blood pressure (DBP) at trough (24 hours post-dosing) at the last observation during the double-blind phase. [ Time Frame: 8 weeks ]

Secondary Outcome Measures:
  • Change from baseline in sitting SBP, standing DBP, standing SBP, sitting and standing heart rate at trough as well as blood pressure control and blood pressure response as defined in study protocol at the last observation will be evaluated. [ Time Frame: 8 weeks ]

Estimated Enrollment: 31
Study Start Date: March 2004
Estimated Study Completion Date: March 2005
Primary Completion Date: March 2005 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Mild to moderate hypertension as defined by a morning mean(>95 and <115mmHg) of two diastolic blood pressure measurements (DBP) after 5 min in the sitting position following a minimum 2-week placebo run in phase.Mean sitting systolic blood pressure (SBP) must be >140 and <200mmHg. The mean DBP and SBP values are calculated as the mean of the two sitting measurements taken 2 min apart just before the drug intake.
  2. Male or female between 20 to 80 years old
  3. Ability to provide written informed consent.

Exclusion Criteria:

  1. Patients are still taking more than three anti-hypertensives at the screening visit
  2. Pre-menopausal women
  3. Known or suspected secondary hypertension
  4. Mean sitting DBP<95mmHg and/or mean sitting SBP > 200mmHg at the end of placebo run-in phase
  5. Hepatic and/or renal dysfunction
  6. Known bilateral renal artery stenosis, patient with a solitary kidney, post renal transplant
  7. Known NYHA functional class Chronic Heart Failure (CHF) III, IV
  8. Unstable angina, myocardial infarction, cardiac surgery or stroke within the preceding six months
  9. Post-Transluminal Coronary Angioplasty(PTCA) within the preceding three months
  10. Sustained ventricular tachycardia, atria fibrillation, second or third degree AV block, VPC or APC (>10% of heart rate) or other clinically relevant cardiac arrhythmia as determined by the clinical investigator
  11. Hypertrophic obstructive cardiomyopathy, aortic stenosis, hemodynamically relevant stenosis of aortic or mitral valve.
  12. Once documented evidence by ophthalmological examination of significant retinal haemorrhages/ exudates
  13. Clinically significant sodium depletion as defined by serum sodium level less than 130 mmol/L
  14. Clinically significant hyperkalemia as defined by serum potassium level >5.5 mmol/L
  15. Non-insulin dependent DM poorly controlled whicih is defined as HbA1c>8% twice consecutively within 6 months and/or AC blood sugar>180 mg/dl.
  16. Insulin Dependent Diabetes Mellitus
  17. Chronic administration of oral anticoagulants and/or digoxin within the past 6 months.
  18. Known drug or alcohol dependency
  19. Administration of medication known to affect blood pressure, except medication allowed by the protocol
  20. Angioedema with ACE inhibitors
  21. Use of nitrates
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00133185

Locations
Taiwan
Machay Memorial Hospital
Taipei, Taiwan, 104
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Study Coordinator B.I. Taiwan Ltd.
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00133185     History of Changes
Other Study ID Numbers: 502.406
Study First Received: August 22, 2005
Last Updated: November 18, 2013
Health Authority: Taiwan: Department of Health

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Hydrochlorothiazide
Losartan
Telmisartan
Benzoates
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Antifungal Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on July 22, 2014